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Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

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ClinicalTrials.gov Identifier: NCT02528721
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Condition Helicobacter Pylori Infection
Intervention Device: Dual Mode BreathID Hp System
Enrollment 282
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects
Hide Arm/Group Description

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Period Title: Overall Study
Started 203 79
Completed 196 76
Not Completed 7 3
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects Total
Hide Arm/Group Description

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Total of all reporting groups
Overall Number of Baseline Participants 196 76 272
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 196 participants 76 participants 272 participants
48.5  (14.94) 49.0  (15.53) 48.64  (15.11)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants 76 participants 272 participants
Female
116
  59.2%
48
  63.2%
164
  60.3%
Male
80
  40.8%
28
  36.8%
108
  39.7%
1.Primary Outcome
Title Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy
Hide Description Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects
Hide Arm/Group Description:

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Overall Number of Participants Analyzed 179 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent positive agreement
98.32
(95.18 to 99.65)
98.53
(92.08 to 99.96)
2.Primary Outcome
Title Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy
Hide Description Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects
Hide Arm/Group Description:

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Overall Number of Participants Analyzed 179 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent negative agreement
97.9
(93.99 to 99.57)
100
(93.51 to 100)
3.Primary Outcome
Title Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy
Hide Description Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results ("composite reference standard"), the subject is considered "unevaluable" and thus not included in the analysis.
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects
Hide Arm/Group Description:

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Overall Number of Participants Analyzed 179 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent overall agreement
98.33
(95.21 to 99.65)
100
(94.72 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Initial Diagnosis Subjects Post Therapy Subjects
Hide Arm/Group Description

Patients with clinical indication for H.pylori infection

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months

Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device

All-Cause Mortality
Initial Diagnosis Subjects Post Therapy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Initial Diagnosis Subjects Post Therapy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/203 (0.00%)      0/79 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Initial Diagnosis Subjects Post Therapy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/203 (1.97%)      1/79 (1.27%)    
Gastrointestinal disorders     
Cyst  [1]  1/203 (0.49%)  1 0/79 (0.00%)  0
Gastric ulcer  [2]  1/203 (0.49%)  1 0/79 (0.00%)  0
General disorders     
Nausea  [3]  2/203 (0.99%)  2 0/79 (0.00%)  0
Lightheadedness  [4]  0/203 (0.00%)  0 1/79 (1.27%)  1
Indicates events were collected by systematic assessment
[1]
Cyst discovered on epiglottis during standard EGD procedure
[2]
Gastric ulcer discovered during EGD procedure
[3]
Nausea experienced for two minutes after drinking test substrate
[4]
Lightheadedness due to fasting for standard EGD procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: VP of Clinical Affairs
Organization: Exalenz Bioscience
Phone: 972-8-9737502
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02528721     History of Changes
Other Study ID Numbers: DM2-HP-0715
First Submitted: August 17, 2015
First Posted: August 19, 2015
Results First Submitted: November 16, 2016
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017